Must study interventions be currently billable/insurance-reimbursable services?

No, the interventions do not need to be currently reimbursable services. However, as noted above, PCORI will not cover patient care costs related to the intervention if it is not currently considered an insurance-covered service by most payers. The study team is expected to propose a plan regarding how any such costs, if any, may be covered. In certain circumstances, PCORI may cover co-payments for participating subjects to ensure equal access to an intervention for vulnerable populations or to preserve blinding. Please also refer to Appendix 2 of the Application Guidelines for more information.